Dedicated to combating neglected and hard-to-treat cancers, iOnctura is developing new treatments with precision oral small molecules that target cancers in novel ways. Their lead asset, Roginolisib, is an allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. The PI3K signalling pathway is one of the most commonly dysregulated pathways in cancer and the precise targeting of the PI3Kδ isoform delivers substantial anti-tumor effects with a low-toxicity profile. The company has completed its Phase I DIONE-01 study in solid and hematological malignancies including uveal melanoma (UM), a rare cancer of the eye. The two-part Phase I study met its primary objective to determine the safety of the anticipated optimal biologically effective dose. The drug was well tolerated over long periods of treatment, up to 4.5 years.
Oculis Phase 2 ACUITY trial meets primary safety end-points
Oculis, with its mission to save sight and improve eye care, has yielded positive topline results with OCS-05 in the Phase 2 ACUITY trial a neuroprotective candidate, in patients with acute optic neuritis. The Acuity (Acute OptiC NeUrITis of DemYelinating Origin) trial was a randomized, double-blind, placebo-controlled, multi-center trial, designed to evaluate OCS-05 administered intravenously once-daily for five days in patients with acute optic neuritis also receiving steroid. The study randomized 36 patients with recent onset (visual loss symptoms) of unilateral acute optic neuritis with a demyelinating origin, of which 33 patients received treatment and were included in the pre-specified modified intent-to-treat (mITT) analysis. Positive results from the ACUITY trial showed that OCS-05 achieved a primary safety endpoint in addition to highlighting neuroprotective structural benefit and the ability to improve visual function in patients suffering from acute optic neuritis.
Positive interim results for Muvon Therapeutics
MUVON Therapeutics, a University of Zurich spin-off, focused on developing a novel platform for the regeneration of skeletal muscle tissue targeting Stress Urinary Incontinence which affects over 200 million women globally, has recently received interim data from its ongoing phase 2 clinical study SUISSE MPC2 study (NCT05534269). The interim readout of the study assessing the safety and efficacy of MUVON’s Muscle Precursor Cell (MPC)-based therapy in Stress Urinary Incontinence included evaluable data from 10 female patients with at least 6-months follow-up post injection of the tissue engineered product into the urethral sphincter muscle. Based on the interim data, the international Data Safety Monitoring Board recommended study continuation, putting the company on track for the release of the final data from the completed phase 2 study in Q3 2025.
Moonlake initiates three new clinical trials
MoonLake Immunotherapeutics, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, announced that patients have been screened in three new trials across three new indications to evaluate sonelokimab, an investigational Nanobody® designed to treat inflammatory disease. The clinical program for sonelokimab now includes patients with adolescent hidradenitis suppurativa (HS), palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA), in addition to adult patients with HS and active psoriatic arthritis (PsA). This increases the number of clinical trials led by MoonLake to ten and aligns with the plan to enroll over 3,000 patients in clinical trials with sonelokimab since the Company was founded in 2021.
Evidence indicates that activation of IL-17A and IL-17F plays a crucial role in the pathophysiology of these inflammatory diseases. Sonelokimab is designed to directly target sites of inflammation by inhibiting all relevant IL-17 dimers, namely the IL-17A/A, IL-17A/F, and IL-17F/F dimers, and to penetrate difficult-to-reach inflamed tissues. The initiation of the Phase 3 VELA-TEEN trial in HS, the Phase 2 LEDA trial in PPP and the Phase 2 S-OLARIS trial in axSpA expands the portfolio of sonelokimab to large dermatology and rheumatology indications, where significant unmet needs remain. Phase 2 and Phase 3 data read-outs across all target indications are expected in 2025 (adult HS, and PPP) and 2026 (adolescent HS, PsA and axSpA).
Mark Lebwohl, MD, Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and Chairman Emeritus, Kimberly and Eric J. Waldman Department of Dermatology commented: “Palmoplantar pustulosis is a chronic, recurrent inflammatory condition affecting the palms and soles, marked by aggressive pustule eruptions, skin destruction, and severe pain. This ongoing skin damage is debilitating, significantly impacting patients’ daily lives and activities. Despite the severity, advanced therapies remain scarce. It is exciting to see studies with innovative technologies like nanobodies to address this urgent medical need.”
(Press release / RAN)